A Professional-Caliber Contract Research Organization with Top Academic Expertise

  • Clinical Coordination
  • Biostatistics & Data Management
  • Therapeutic Expertise
  • Recent Sponsored Trials
  • Clinical Coordinating Center (CCC)
  • Centralized CT Reading Center
  • Surgical Support Center
  • Investigator Selection & Qualification
  • Clinical Site Management
  • Safety & Pharmacovigilance
  • On-site and Remote QA Monitoring
  • Regulatory (IND, IDE, GCP)
  • Data Coordinating Center (DCC)
  • Clinical Data Management
  • Advanced Biostatistics
  • Adaptive Randomization
  • Electronic Data Capture (EDC)
  • Electronic Trial Master File (eTMF)
  • Clinical Trial Management System (CTMS)
  • Online Training & Certification
  • Hemorrhagic Stroke (ICH, IVH)
  • Ischemic Stroke, TIA
  • Global Ischemia
  • Traumatic Brain Injury (TBI)
  • Encephalitis
  • Functional & Cognitive Outcomes
  • Epilepsy
  • Neurosurgery
  • CLEAR A, a 16-patient phase-1 study of thrombolysis in IVH
  • CLEAR B, a 34-patient, phase-1 study of thrombolysis in IVH
  • MISTIE-II, a phase-II trial of thrombolysis in ICH
  • MISTIE-ICES, endoscopic evacuation in ICH
  • CLEAR-III, a 500-patient global trial in IVH
  • MISTIE-III, a 500-patient global trial in ICH
  • SLEUTH, feasibility of an ultrasound catheter in ICH
  • CARES, an 88-patient observational study

About BIOS

The Johns Hopkins Brain Injury OutcomeS (BIOS) Division is a clinical trial coordinating center (data management center, imaging reading center, and enrollment center) within the Johns Hopkins School of Medicine, Department of Neurology. Its focus is to provide multicenter management to clinical trials evaluating therapeutic, preventive and diagnostic interventions. Led by Dr. Daniel F. Hanley, BIOS has unique expertise in the coordination and management of trials investigating rare neurologic disorders, acute neurologic ICU conditions, rehabilitation, and functional outcomes. Since the 1990s, BIOS has coordinated international, federally-funded and industry-sponsored trials across a wide range of conditions for investigators within the JHU departments of Neurology, Neurosurgery, Anesthesia-Critical Care Medicine, Hematology, Neuroradiology, and for investigators at other academic centers around the U.S.

BIOS has managed trials for stroke, neurological critical care, infectious disease, cardiovascular disease, cardiac arrest, and neuromuscular disorders as well as other brain and stroke-related disciplines. BIOS has coordinated trials testing drugs and devices to treat stroke, both ischemic and hemorrhagic, brain infections, muscular dystrophy, sickle cell disease, and brain trauma within the Johns Hopkins University, around the nation, in Canada and Israel, and throughout the European Union.

BIOS maintains a high level of research activity and has received substantial funding dollars from a variety of studies sponsored by the FDA Office of Orphan Products Development (rare diseases), NHBLI SBIR and DOD mechanisms, NINDS, NIAID, Department of Veterans Affairs, Washington State, the American Academy of Neurology, the American Heart Association, the Doris Duke Foundation, Genentech and several pharmaceutical organizations, and device companies, such as the EKOS Corporation and Infinite Biomedical Technologies via small business and Defense contracting.

Previous NIH trials include BIOS studies of acute viral encephalitis – “Adult HSE trials” (funded by National Institute of Allergy and Infectious Diseases [NIAID]); viral meningitis – “West Nile Virus trials” (NIAID) and acute hemispheric stroke – “Induced-Hypertension trial” (NINDS).  Active trials with international coordination responsibilities include: intraventricular hemorrhage – “CLEAR III trial” (NINDS and prior FDA orphan drug program); ATACH (NINDS) and parenchymal hemorrhage “MISTIE trial” (NINDS).  In addition, the group has pioneered the translation of laboratory-based, diagnostic and therapeutic measurements for the treatment of brain injury from global ischemia after cardiac arrest -- “CARES trial” (National Heart Lung and Blood Institute [NHLBI]). Currently, BIOS focuses on providing multicenter coordinating infrastructure to neurological clinical trials evaluating therapeutic, preventive and diagnostic interventions for stroke, and more recently, pediatric hematologic disease (sickle cell and silent stroke).

In each clinical area, BIOS has developed novel standardized clinical protocols and clinical assessment tools, using investigator consensus methods. BIOS has pioneered the use of surrogate measures from brain images to assess disease state and severity in different types of brain injury and is developing unique statistical methods to assess brain disease severity and the impact of neurologic treatments on clinical and surrogate measures of brain injury. And, tools from “first of a kind” BIOS trials have been adopted in subsequent trials by others. BIOS offers quality-controlled collection and validation routines for detailed neurological data and has extensive experience designing precise, unambiguous point-of-care tools designed to report and analyze:

  • Injury, recovery and outcomes
  • Surgical and ICU protocols and performance
  • Medical event tracking
  • Timeline analyses comparing physiologic measurements to dosing and adverse events, and performance within timeframes

BIONIC Reading Center

The Reading Center at Johns Hopkins BIOS Division operates as a fully functional image lab designed for the reading, grading, and analysis of patient studies consisting of CT, MRI, f-MRI, CT angiography, and MRI angiography scans, as well as other types of diagnostics studies.  Well equipped with state-of-the art digital imaging equipment and software, the Reading Center is capable of conducting sophisticated volume, area, and distance analyses on a wide range of pathological, physiological, and anatomical features of specific interest to a given clinical trial—specifically addressing safety, efficacy, and quality control. Equally, the Reading Center conducts comprehensive qualitative analyses for all trials hosted by the BIOS Coordinating Center, as well as other government and privately funded studies through contract agreement. With full time staff, technicians, radiologists, and clinicians, the BIOS Reading Center is well equipped and qualified to service most any clinical trial’s imaging needs. 

ICTR

The Johns Hopkins Institute for Clinical and Translational Research (ICTR), established in 2007, is one of more than 60 medical research institutions working together as a national consortium to improve the way biomedical research is conducted across the country. The ICTR addresses obstacles in translating basic science discoveries into research in humans, translating clinical discoveries into the community and communicating experience from clinical practice back to researchers.

BIOS and ICTR, together with investigators from Tufts University, won a seven-year award from the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS) to form one of only three new national Trial Innovation Centers (TICs) that will provide high-quality design and operational support to investigators conducting multi-center clinical trials.